Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis

Phase 2

Completed

• Conditions: Brain Metastasis
• Interventions: Drug: Trental; Dietary Supplement: Vitamin E

• Registration Number: NCT01508221
• Lead Sponsor: University of Cincinnati

Brief Summary

The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.

Detailed Description

The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. Follow-up appointments will be every 3 months for 1 year at which time, your participation in the study will be concluded.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-01-08
• Study First Submitted QC: 2012-01-08
• Study First Posted: 2012-01-11
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Results First Submitted: 2023-06-08
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Results First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor
• Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation or by clinical confirmation by the treating physician based on MR imaging characteristics in the setting of a known history of cancer
• Age > 18 years
• Partial or total resection of a metastatic tumor are eligible

Exclusion Criteria

• Known sensitivity to vitamin E or Trental
• Recent intracranial bleed or retinal hemorrhage
• Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
• History of Avastin treatment
• Anticipated need for treatment with Avastin
• History of bleeding disorder
• History of liver disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trental + Vitamin E	Vitamin E	Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment
Trental + Vitamin E	Trental	Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment

Primary Outcome Measures

Name	Time	Method
Number of Participants With Symptomatic Radiation Necrosis	average 1 year	Number of symptomatic death of healthy tissue caused by radiation therapy.

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States